Senior Manufacturing Associate
Pharma UniverseAbout the role
We’re building a high-impact Drug Substance Commercial GMP Manufacturing team at a brand-new, state-of-the-art site in New Jersey – and looking for 5 new Manufacturing Scientists/Associates who thrive in fast-paced, science-driven environments.
You’ll be part of a mission-critical team scaling up biologics manufacturing processes from pilot scale to 2000L single-use bioreactors in preparation for commercial GMP production. This is a unique opportunity to be on the front lines of large-scale biologics manufacturing, supporting first-in-plant execution of clinical and commercial batches in a hands-on, GMP shop floor environment.
Responsibilities:
- Perform cell culture operations including seed expansion, cell inoculation, cell growth monitoring, and harvest in single-use bioreactors (SUBs) up to 2000L
- Prepare and operate equipment for media and buffer preparation, seed train, and clarification processes (e.g., depth filtration)
- Accurately execute GMP batch records, logbooks, and documentation in real time
- Ensure aseptic technique and contamination control in cleanroom environments
- Support facility and equipment readiness, including area/equipment prep, cleaning, and turnover
- Follow cGMP, EHS, and SOP guidelines with precision and consistency
- Participate in shift-based operations (including potential nights/weekends on rotation)
Qualifications
- Associate’s or Bachelor’s degree in Biotechnology, Biochemistry, or related field
- 2-6+ years of experience in upstream biologics manufacturing (Associate II/III level)
- Hands-on experience with bioreactor operations, seed train, and clarification required
- Comfortable working in a GMP cleanroom with strict gowning and hygiene procedures
- Reliable, detail-oriented, and team-focused with excellent documentation habits
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